Trintellix 10mg Tb (was Brintellix)
WARNING: In some studies, drugs used for depression raised the risk of suicidal thoughts or actions in children and young adults. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.
Drug Class
Antidepressant
Pharmacologic Class
Serotonin Modulator and Stimulator (SMS)
Pregnancy Category
Not available
FDA Approved
Sep 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Trintellix is a medication used to treat depression. It works by affecting several chemical messengers in the brain, particularly serotonin, to help improve mood and other symptoms of depression. It's important to take it regularly as prescribed, even if you start feeling better.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When you're finished with your medication or it expires, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When you're finished with your medication or it expires, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take Trintellix exactly as prescribed, usually once daily with or without food.
- Do not stop taking Trintellix suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol while taking Trintellix, as it can worsen side effects like dizziness or drowsiness.
- Be cautious when driving or operating machinery until you know how Trintellix affects you, as it may cause dizziness or blurred vision.
- Report any unusual bleeding or bruising to your doctor, especially if you are also taking blood thinners.
- Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 10 mg orally once daily. May increase to 20 mg once daily or decrease to 5 mg once daily based on tolerability and clinical response.
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial 10 mg orally once daily. Target dose 10-20 mg once daily. Some patients may tolerate 5 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
No specific recommendations; vortioxetine is highly protein bound and unlikely to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
Consider a lower dose (e.g., 5 mg/day) due to potential for increased exposure. Use with caution.
Pharmacology
Mechanism of Action
Vortioxetine is a multimodal antidepressant. It is thought to exert its antidepressant effects through a combination of mechanisms: inhibition of serotonin (5-HT) reuptake, antagonism of 5-HT3, 5-HT1D, and 5-HT7 receptors, partial agonism of 5-HT1B receptors, and agonism of 5-HT1A receptors. This multimodal action is believed to modulate neurotransmission in several systems, including serotonin, norepinephrine, dopamine, histamine, and acetylcholine.
Pharmacokinetics
Absorption:
Bioavailability:
75%
Tmax:
7-11 hours
FoodEffect:
Food has no clinically significant effect on absorption.
Distribution:
Vd:
2600 L
ProteinBinding:
>98%
CnssPenetration:
Yes
Elimination:
HalfLife:
66 hours (approximately 2.75 days)
Clearance:
Not available
ExcretionRoute:
Renal (urine) and Fecal
Unchanged:
<1% (urine), <1% (feces)
Pharmacodynamics
OnsetOfAction:
Antidepressant effects typically begin within 1-2 weeks, with full effect often seen by 2-4 weeks.
PeakEffect:
Clinical response typically peaks within 2-4 weeks of stable dosing.
DurationOfAction:
Due to its long half-life, effects persist for several days after discontinuation, but clinical effects require daily dosing.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Trintellix or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults older than 24 years; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trintellix is not approved for use in pediatric patients.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Trouble sleeping
Severe dizziness or fainting
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Eye problems, such as:
+ Eye pain
+ Changes in vision
+ Swelling or redness in or around the eye
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Diarrhea
Nausea or vomiting
Upset stomach
Dry mouth
Dizziness
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Trouble sleeping
Severe dizziness or fainting
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Eye problems, such as:
+ Eye pain
+ Changes in vision
+ Swelling or redness in or around the eye
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Diarrhea
Nausea or vomiting
Upset stomach
Dry mouth
Dizziness
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or anxiety
- New or increased thoughts of self-harm or suicide
- Panic attacks
- Agitation, restlessness, or irritability
- Aggressive or violent behavior
- Unusual changes in mood or behavior
- Severe nausea or vomiting
- High fever, sweating, confusion, muscle rigidity, or rapid heart rate (signs of serotonin syndrome)
- Unusual bleeding or bruising
- Eye pain, changes in vision, or swelling or redness in or around the eye (signs of angle-closure glaucoma)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days, as this may increase the risk of very high blood pressure
Other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as this medication may interact with them
Any health problems you have, as they may affect the safety of taking this medication
Please note that this is not an exhaustive list of all potential interactions or health problems that may be relevant. It is crucial to consult with your doctor and pharmacist to ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days, as this may increase the risk of very high blood pressure
Other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as this medication may interact with them
Any health problems you have, as they may affect the safety of taking this medication
Please note that this is not an exhaustive list of all potential interactions or health problems that may be relevant. It is crucial to consult with your doctor and pharmacist to ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you.
Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of experiencing side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage to minimize potential risks.
Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
When treating depression, you may notice improvements in sleep and appetite soon after starting this medication. However, other symptoms of depression may take up to 4 weeks to show significant improvement.
As this medication may interfere with certain laboratory tests, ensure that your doctor and laboratory personnel are aware that you are taking this medication.
Be aware that this medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor to discuss this potential risk.
Additionally, this medication may cause low blood sodium levels, which can be fatal in severe cases. Consult your doctor if you have any concerns.
If you are following a low-salt or salt-free diet, inform your doctor, as this may affect your treatment plan.
To avoid medication errors, always verify that you have the correct medication by checking the shape, color, size, and packaging. If you notice any changes, consult your pharmacist.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy or breastfeeding.
Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you.
Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of experiencing side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage to minimize potential risks.
Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
When treating depression, you may notice improvements in sleep and appetite soon after starting this medication. However, other symptoms of depression may take up to 4 weeks to show significant improvement.
As this medication may interfere with certain laboratory tests, ensure that your doctor and laboratory personnel are aware that you are taking this medication.
Be aware that this medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor to discuss this potential risk.
Additionally, this medication may cause low blood sodium levels, which can be fatal in severe cases. Consult your doctor if you have any concerns.
If you are following a low-salt or salt-free diet, inform your doctor, as this may affect your treatment plan.
To avoid medication errors, always verify that you have the correct medication by checking the shape, color, size, and packaging. If you notice any changes, consult your pharmacist.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy or breastfeeding.
Overdose Information
Overdose Symptoms:
- Nausea
- Dizziness
- Diarrhea
- Abdominal discomfort
- Pruritus (itching)
- Somnolence (drowsiness)
- Flushing
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive and symptomatic.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of stopping an MAOI, or starting an MAOI within 21 days of stopping vortioxetine (risk of serotonin syndrome).
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
- Strong CYP2D6 inhibitors (e.g., bupropion, fluoxetine, paroxetine, quinidine) - reduce vortioxetine dose by half.
- Strong CYP inducers (e.g., rifampin, carbamazepine, phenytoin) - consider increasing vortioxetine dose (up to 3x the original dose) if co-administered for more than 14 days.
Moderate Interactions
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Depression severity (e.g., PHQ-9, HAM-D)
Rationale: To establish baseline symptom severity and track treatment response.
Timing: Prior to initiation of therapy
Suicidal ideation/behavior assessment
Rationale: To identify baseline risk, especially in young adults, and monitor for worsening.
Timing: Prior to initiation of therapy
Blood pressure and heart rate
Rationale: To establish baseline and monitor for potential cardiovascular effects, though generally minimal.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response to therapy (symptom improvement)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Reduction in symptom scores, improved functioning
Action Threshold: Lack of improvement or worsening of symptoms may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., nausea, sexual dysfunction, insomnia)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Suicidal ideation/behavior
Frequency: Especially during initial treatment and dose changes, then regularly as clinically indicated
Target: Absence of new or worsening suicidal thoughts/behaviors
Action Threshold: Any new or worsening suicidal ideation/behavior requires immediate clinical assessment and intervention.
Weight
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant weight changes may warrant investigation or intervention.
Symptom Monitoring
- Worsening depression
- New or worsening anxiety
- Agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania/mania
- Suicidal ideation or attempts
- Nausea
- Constipation
- Sexual dysfunction
- Abnormal bleeding/bruising
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Exposure to SSRIs/SNRIs in late pregnancy has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show some developmental toxicity at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia).
Lactation
Vortioxetine is excreted into human milk. The decision to breastfeed during treatment should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Trintellix, and any potential adverse effects on the breastfed infant from Trintellix or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.
Infant Risk:
Low to moderate risk. Limited data, but potential for infant exposure and adverse effects. L3 (Moderately Safe) rating by some sources.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Trintellix is not approved for use in patients under 18 years of age. A black box warning exists regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults with antidepressant use.
Geriatric Use
No dose adjustment is generally required based on age alone. However, elderly patients may be more sensitive to the effects of antidepressants and may have a higher risk of hyponatremia. Monitor for adverse effects and clinical response.
Clinical Information
Clinical Pearls
- Vortioxetine has a unique multimodal mechanism of action, affecting multiple serotonin receptors in addition to serotonin reuptake inhibition, which may offer benefits beyond traditional SSRIs/SNRIs, particularly in cognitive symptoms of depression.
- Nausea is a common dose-dependent side effect, especially during initiation. Taking with food or at bedtime may help. It often subsides over time.
- Unlike many other antidepressants, vortioxetine has a relatively low incidence of sexual dysfunction, which can be a significant advantage for some patients.
- Due to its long half-life, it takes several days to reach steady-state concentrations and for drug levels to decline after discontinuation, which can lead to a more gradual onset/offset of effects.
- Careful monitoring for serotonin syndrome is crucial when co-administered with other serotonergic agents.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) e.g., venlafaxine, duloxetine, desvenlafaxine
- Atypical Antidepressants e.g., bupropion, mirtazapine, trazodone
- Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline
- Monoamine Oxidase Inhibitors (MAOIs) e.g., phenelzine, tranylcypromine (reserved for refractory cases)
- Electroconvulsive Therapy (ECT)
- Transcranial Magnetic Stimulation (TMS)
- Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
Cost & Coverage
Average Cost:
$400 - $600 per 30 tablets (10mg)
Insurance Coverage:
Tier 2 or Tier 3 (Preferred or Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was taken.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was taken.